Sr. Manager/Manager Quality Risk Manager

Just-Evotec Biologics is seeking a highly motivated Sr. Manager Quality Risk Manager, that desires a significant opportunity to improve worldwide access to biotherapeutics.

The position is part of the Just-Evotec Biologics Quality team and will report directly to the Director of QMS. In this role, the successful candidate will:

• Set Quality Risk Management strategy with input from relevant business partners and management. This will include developing strategy documents (policies and guidance) as well as writing detailed processes and procedures.
• Directs the strategy for design, deployment and continuous improvement of the global and local Quality Risk Management Program including the company’s risk register.
• Participate with both internal and external audits to ensure compliance with current regulations.
• Work closely with training groups to assist in the continual development of and use of relevant tools for Risk Management.
• Initiation and approval of change controls to determine impact of changes to facility, utilities, equipment, process/product as applicable, and system owners.
• Investigation and approval of exceptional conditions during the execution of protocols as well as other atypical events, deviations, and non-conformances as required.
• Supports regulatory inspections as necessary.
• Other duties as required.

Educational Requirements:

• BS, MS. in Biochemistry, Biology, Microbiology, Chemistry or a Scientific/Engineering degree
• 6+ years of in biotechnology or biopharmaceutical experience in a commercial manufacturing environment.

Qualification Requirements:

• knowledge of cGMP in the pharma/Biotech industry
• Ability to troubleshoot, identify root cause and systematically resolve problems.
• The ability to represent the team cross-functionally; to apply an understanding of the team’s place in the larger organization, and discuss changes, progress, and issues as they relate to other areas.
• The ability to effectively build and maintain relationships with across the organization in order to effectively solve problems.
• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
• The ability to enable and drive change while being focused on internal and external customers.
• Excellent communication skills both verbally and written; and with various organizational levels internally and externally.
• Capable to manage multiple priorities and maintain adherence to timelines.
• Good interpersonal, team, and communication skills are a must
• Ability to communicate effectively over teleconference and web-based meetings are necessary.

The base pay range for this position at commencement of employment is expected to be $125,000 to $165,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.